Keystone

Product NDC: 47593-561
11-digit product format: 475930561
Labeler code: 47593
Product ID: 47593-561_695c97a6-c8c3-4632-9d45-77f135840db3
Type: HUMAN OTC DRUG
Nonproprietary name: Benzalkonium Chloride
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Ecolab Inc.
Application: 505G(a)(3)
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-12-21
Substance: BENZALKONIUM CHLORIDE
Active strength: 5 mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Keystone
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZALKONIUM CHLORIDE	5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
F5UM2KM3W7	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1731737	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6860a80e-9a5f-40e4-bec3-e7386e541f5b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
47593-561-41	Keystone	750 mL in 1 BOTTLE, PLASTIC	SOLUTION	750		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
47593-561	KEYSTONE (BENZALKONIUM CHLORIDE) SOLUTION [ECOLAB INC.]	3	Current NDC, Legacy NDC, 1 package rows	20240731_6860a80e-9a5f-40e4-bec3-e7386e541f5b.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Keystone	BENZALKONIUM CHLORIDE	Ecolab Inc.	6860a80e-9a5f-40e4-bec3-e7386e541f5b	2024-07-30	Warnings	Exact identifier ndc (product): 47593-561

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F5UM2KM3W7	BENZALKONIUM CHLORIDE	8001-54-5	BENZALKONIUM CHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1731737	benzalkonium chloride 0.5 % Medicated Liquid Soap	PSN	6860a80e-9a5f-40e4-bec3-e7386e541f5b	3
1731737	benzalkonium chloride 5 MG/ML Medicated Liquid Soap	SCD	6860a80e-9a5f-40e4-bec3-e7386e541f5b	3
1731737	benzalkonium chloride 0.5 % Medicated Liquid Soap	SY	6860a80e-9a5f-40e4-bec3-e7386e541f5b	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
47593-561-41	47593056141	750 mL in 1 BOTTLE, PLASTIC (47593-561-41)	750 ml	2016-12-21	0000-00-00	No	No	Current